(1) “ …. where the risk is fully characterised and appropriately managed, important identified risks may be removed from the safety specification…” (2) “…From the identified risks and potential risks …. the RMP should address only the risks that are undesirable clinical outcomes...” (3) “…An important identified risk to be included in the RMP would usually warrant further evaluation as a part of the pharmacovigilance plan, or risk minimisation activities” (4) “…Important potential risks can be removed from the RMP when accumulating scientific and clinical data do not support the initial supposition or when the impact of the potential risk is less than anticipated resulting in the potential risk not being considered important” (5) “Important potential risks included in the RMP would usually require further evaluation as part of the pharmacovigilance plan” (6) “...the classification as missing information might not be appropriate anymore once new data become available…” (7) “...the RMP should focus on those risks that are relevant for the risk management activities for the authorised product”